BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L-BONE PLATE, MP, 4 HOLE, LEFT, SHORT

    MDR report key: 2801306 · Received October 17, 2012

    Report

    Report Number
    8010177-2012-00224
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 24, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K022185
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Description of Event or Problem · 1

    PLATE WAS REPORTED TO HAVE FRACTURED WHILST BEING BENT WITH THE 3 PRONG BENDER. ANOTHER ITEM WAS USED INSTEAD AND CASE WAS COMPLETED AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L-BONE PLATE, MP, 4 HOLE, LEFT, SHORT IMPLANT JEY STRYKER OSTEOSYNTHESIS FREIBURG NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK